NDC 44237-047

Novex Diphenhydramine

Diphenhydramine Hydrochloride

Novex Diphenhydramine is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Herbion Pakistan (pvt.) Ltd. The primary component is Diphenhydramine Hydrochloride.

Product ID44237-047_e280f9fe-3985-41d4-8ded-0d940fbd0e9d
NDC44237-047
Product TypeHuman Otc Drug
Proprietary NameNovex Diphenhydramine
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-04-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHerbion Pakistan (Pvt.) Ltd
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 44237-047-06

3 BLISTER PACK in 1 CARTON (44237-047-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2020-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44237-047-06 [44237004706]

Novex Diphenhydramine TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-09

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:7167d03c-448f-422d-a982-d9b852f86f79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630

    • NDC Crossover Matching brand name "Novex Diphenhydramine" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    44237-047Novex DiphenhydramineNovex Diphenhydramine
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride
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